Green Light for BioCardia Study Following Interim Safety Analysis

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Cardiovascular Regenerative therapies company, BioCardia tells us that the independent Data Safety Monitoring Board (DSMB) has indicated there were no significant safety concerns with the CardiAMP study results and recommended that the trial continue, as planned.


CardiAMP therapy is designed to stimulate the body’s natural healing response. It delivers a high target dose of 200 million mononuclear cells directly to injured cardiac tissue using a proprietary delivery system. A few weeks ago we covered the news that the so-called Helix™ transendocardial delivery system had been deemed safe following positive 12-month results from its Phase II TRIDENT clinical trial.

With the positive news from the DSMB, the ongoing 260 patient trial can now continue. This multi-center, double-blinded, randomized (3:2), sham-controlled Phase 3 trial will evaluate CardiAMP cell therapy in adult patients with heart failure that develops following a heart attack.

The trial’s primary efficacy endpoint is a significant improvement in Six Minute Walk distance at 12 months post-treatment. It also incorporates the impact of major adverse cardiac events and other clinically meaningful events.

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